NCT01302275

Brief Summary

The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2011

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

February 23, 2011

Last Update Submit

May 2, 2014

Conditions

PolyneuropathyPeripheral Nerve InjuryPostherpetic Neuralgia

Keywords

neuropathic painoxcarbazepinepain mechanism

Outcome Measures

Primary Outcomes (1)

  • Total pain rated on numeric rating scale

    Pain is rated daily on 0-10 point numeric rating scales. From the daily ratings from week 6 of each treatment period a median value is determined and used for data analysis. The analysis will compare scores between treatments (oxcabazepine vs placebo) and treatment effects (placebo-oxcarbazepine) between groups irritable nociceptor vs non-irritable nociceptors and some other subgroups.

    Measurements from week 6 of treatment period

Secondary Outcomes (7)

  • Response defined as at least 50% reduction in pain score

    Week 6 of each treatment period vs. baseline

  • Neuropathic Pain Symptom Inventory

    Week 6 of each treatment period

  • Patient Global Impression of Change

    Week 6 of each treatment period

  • Rating of evoked pain

    Week 6 of each treatment period

  • Sleep disturbance

    Week 6 of each treatment period

  • +2 more secondary outcomes

Study Arms (2)

oxcarbazepine

EXPERIMENTAL

Oxcarbazepine is gradually increased during 21 days from 300 mg x 1 daily to 2400 mg, and kept on that dose ( 2400 mg) for three weeks.

Drug: Oxcarbazepine

placebo

PLACEBO COMPARATOR
Drug: Oxcarbazepine

Interventions

OxcarbazepineDRUG

Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day

Also known as: Trileptal
oxcarbazepineplacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years old
  • definite or probable neuropathic pain
  • diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
  • pain duration \> 3 months
  • pain rating at baseline \>= 4 point NRS
  • Informed consent

You may not qualify if:

  • other non-neuropathic pain condition
  • allergy to oxcarbazepine
  • renal or hepatic impairment
  • epilepsy
  • depression and other serious psychiatric disorders
  • serious medical condition
  • previous treatment for neuropathic that cannot be stopped
  • pregnancy
  • patients expected not to be able to comply with study protocol
  • treatment with anticonvulsants, antidepressant or opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Neurology, Odense University Hospital

Odense, DK-5000, Denmark

Location

MeSH Terms

Conditions

PolyneuropathiesPeripheral Nerve InjuriesNeuralgia, PostherpeticNeuralgia

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Søren H Sindrup, MD

    Department of Neurology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 24, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

DK(2)